Identity
- Trade Name
- Symmetry Shea FDA UDI
- Generic Name
- Robotic surgical navigation system application software FDA UDI
- Device Name
- Symmetry® Hook, Shea Stapes, 20° Angle, 0.5 mm FDA UDI
- Model / Reference
- 62-0445 FDA UDI
- Description
- Symmetry® Hook, Shea Stapes, 20° Angle, 0.5 mm FDA UDI
Identifiers
- Catalog Number
- 62-0445 FDA UDI
- Primary DI / UDI-DI
- 00887482040355 FDA UDI
- FDA Product Code
- GDG FDA UDI
- GMDN Term
- Robotic surgical navigation system application software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Angle — 20 degree FDA UDIWidth — 0.5 Millimeter FDA UDI
Category: Robotic surgical navigation system application software
Symmetry Shea by Symmetry Surgical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical navigation system application software.
- 360CAS — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- 360CAS — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- 360CAS — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- OMNIBotics — OMNIlife science, Inc. · Class II
- ROSA Partial Knee Software V1.0 — Orthosoft Inc · Class II
- ORTHOMAP — Stryker Leibinger · Class II
- 360CAS — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- Mako — MAKO Surgical Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Symmetry Surgical Inc.
Sources (1)
- FDA UDI 3e385d6b-c55f-4918-a062-a6139e7b7acc 36 fields · synced May 30, 2026